Enclosed living cell dispensing tube

ABSTRACT

A dispensing tube containing a selected material, such as bacterial cells or other additive, on the inside of the tube. The tube is wrapped and sealed in an outer watertight envelope until time for usage. At the time of usage the outer envelope is taken away and when the tubular device penetrates a solution container such as a beverage or an enteral solution, the selected material is added to the solution while the solution flows through the tube.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to devices used to add components to packagedliquids, such as beverages.

2. Description of the Related Art

In the pharmaceutical and food industry it is well-known that additionof health-promoting bacteria (e.g. probiotic bacteria such as lacticbacteria or bifido bacteria) allows people to maintain a proper gutfunction. However, it has been difficult and relatively expensive tohave an acceptable shelf life of a mixed product that contains thesebacteria. The problem has been that such drinks or enteral solutions gothrough a thermal sterilization or are aseptically filled inpresterilized containers, thus killing or removing any live bacteriaadded during the production process. If the bacteria are added directlyinto the solution during the production/filling process and aftersterilization, the bacteria are likely to be re-activated by thepresence of water, and would accordingly multiply and finally die withina few weeks or months after production. The metabolites of the bacteriamight also change the solution taste and nutritional value.

To avoid the interaction between the solution and the bacteria prior toingestion, special delivery systems have been integrated into solutioncontainers like e.g., Tetrabrik or Pet bottles (see, for example,co-pending PCT application PCT/US98/21490). Since these delivery systemsare more or less an integral part of the packaging, the producer cannotchoose during or after production to have some of the products have thedelivery system and some not to have it.

Attempts to solve these problems include the use of tubular devices,such as telescopic packaging infusion units formed as tubes from aliquid impermeable material. For example U.S. Pat. No. 3,102,465 andPCT/AAU97/00680 disclose straw-shaped units that can be opened so thatthe ingredient contained in the unit can be dispensed. A number ofpatents, for example, U.S. Pat. Nos. 4,860,929 and 4,986,451, providetubular devices closed on both ends and having perforations along thesides to allow granular material to be released and dissolved in contactwith water or another solvent. Other methods of adding a material to aliquid by means of a straw-device include coating the outside of one endof a straw with a flavored coating that dissolves when the straw isplaced in a liquid or making the end of a straw in the form of a spoonmade of a soluble substance. Other straw-shaped novelty inventionsprovide straws with internal or external decorative features andsubstances.

It is therefore an object of the invention to provide a simple low-costand consumer-friendly system to protect bacteria for an extended term atroom temperature, and have a ready-to-use system for the patient or theuser after this extended term.

It is a further object to provide a device that enable addition todrinks of an ingredient such as a probiotic microorganism, using a strawthat the consumer can then use to sip the drink.

It is a further object of the invention to provide a means of addingprobiotic bacteria or other additives to beverages such as dairyproducts or soft drinks or to enteral solutions which have been throughan aseptic or sterile treatment, e.g., sterile filtration, irradiationor thermal sterilization.

It is a further object of the invention to provide a device for addingcomponents to beverages which has a water and moisture tight containeruntil it is opened and ready for use.

It is a further object of the invention to provide a means for long-termstorage of health promoting bacteria.

It is a further object of the invention to provide a new delivery systemfor other moisture-sensitive or oxygen-sensitive components, such ascertain amino acids, peptides, nucleotides, vitamins, hormones andproteins.

Other objects and advantages will be more fully apparent from thefollowing disclosure and appended claims.

SUMMARY OF THE INVENTION

The invention herein is a dispensing tube containing a selectedmaterial, such as bacterial cells or other additive, on the inside ofthe tube. The tube is wrapped and sealed in an outer watertight envelopeuntil time for usage. At the time of usage the outer envelope is takenaway and when the tubular device penetrates a solution container such asa beverage or an enteral solution, the selected material is added in thedesired amount to the solution while the solution flows through thetube.

Other objects and features of the inventions will be more fully apparentfrom the following disclosure and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of the tube of theinvention.

FIG. 2 is a perspective view of a second embodiment of the tube of theinvention.

FIG. 3 is a perspective view of a third embodiment of the tube of theinvention.

FIG. 4 is a cross-section of a portion of the tube that has an adherentselected material inside the tube.

FIG. 5 is a partial view of a partially sectioned tube end showing thelocation of adherent selected material.

FIGS. 6A-6C depict a coated second tube prior to insertion in theimpermeable tube (FIG. 6A); the coated second tube inserted partway intothe impermeable tube (FIG. 6B); and the rotation of the coated secondtube end and dislodgment of selected material inside the impermeabletube.

FIG. 7 is a perspective view of the device of the invention packaged inan envelope.

DETAILED DESCRIPTION OF THE INVENTION AND PREFERRED EMBODIMENTS THEREOF

The present invention is a dispensing tube having a structure similar tothat of a drinking straw. The dispensing tube is impermeable to liquidsand open at both ends for the purpose of delivering the solution throughthe device normally by sucking. In the preferred embodiment, a selectedmaterial, such as a suspension of typically probiotic microorganism, forexample, lactic bacteria or bifidus bacteria, is added to the dispensingtube as described below. In the preferred embodiments of the invention,during production of the tube of the invention, a second tube deliversthe selected material into the dispensing tube. The tube is then placedinto a water-resistant outer envelope using a packaging machine as isknown in the art. The materials used in the manufacture of theinvention, in particular, the dispensing tube and the outer envelope,must be capable of protecting the bacteria or other selected materialfrom contamination and moisture for periods of up to 12 months storageat room temperature. The tube material must also be able to withstandthe suspension media used for the bacteria or whatever other selectedmaterial is used.

Referring to the figures, the invention herein is a dispensing tube fordispensing a selected material into a liquid, comprising a liquidimpermeable tube 20 having an open bore 22 surrounded by an inner tubewall 24. Bore 22 is open at both an upper end 26 and a lower end 28 ofthe tube as shown in FIGS. 1-3; in other words, the tube is not closedat either end. Tube 20 is preferably of a size and structure as is knownwith drinking straws, such as the straws that are used with boxedindividual drink cartons, and is preferably formed from a syntheticpolymeric material such as polyethylene or polypropylene, or from paperwith an internal coating of a wax material. Preferred dimensions rangefrom a width of 0.2-20 mm and a length of 50-500 mm. The tube may be acommercial drinking straw.

Thus, if tube 20 is to be used with a standard drink box having apuncturable opening, the lower end 28 of the tube is preferably apointed end as shown in FIGS. 1-3 and 7. Other dispensing tubes that maybe used in the invention include those with bellows 44 as is known inthe art (FIG. 2). Since straws used in Japan often have an outer tubeinto which the drinking straw telescopes, the invention herein alsoinclude an embodiment having an outer tube 42 as shown in FIG. 3.

It is important that tube 20 have the capability to hold the suspension,and to hinder the suspension from unintentional leakage out of the tube20. This is accomplished either by surface tension through appropriateselection of the material of which the tube is made or by treatment oftube 20. It also could be done by altering the viscosity of thesuspension. Although not required for the invention, in the preferredembodiments of the invention, the inner wall of the tube is coated or isotherwise surface-modified to give a higher surface tension. Thus, inthe preferred embodiments, the invention further includes a coatingmaterial 30 for holding a suspension of the selected material 32 withinthe open bore 22 adherent to the inner tube wall 24. This coatingmaterial 30 may comprise any coating substance which is non-toxic tohumans and to the bacteria to be added to the tube, and which adheres tothe inner tube wall 24, for example, a dietary oil such as corn oil or awax. The coating material may be applied in a number of ways, forexample, by insertion of an elongated stick or other device coated withthe substance, with a tubular filling device, or by spraying the insideof tube 20.

The bacteria or additive may be applied with the coating substance, orbe separately applied to selected positions inside the tube (forexample, a small drop of about 10 μl) evenly sprayed all over the insideof the tube after coating the inside of tube 20. The pattern and extentof distribution of the additive inside tube 20 may be determined by thenature of the additive and the intended use. Thus, for an easily solubleadditive, even distribution is less critical. If the additive dissolvesquickly and is at the distal end of tube 20, it may be desirable toposition the additive close to the distal end, so that the additivebecomes quickly dispersed in the solution in the container. Anotherreason to position the additive at the distal end is when the additivehas an unpleasant taste, and it is desired to maximally dilute theadditive before it is consumed. Alternatively, when the additive has apleasant taste, it may be positioned at the upper end to increase thegood taste of the drink. To minimize exposure of an oxygen-sensitiveadditive, the additive may be placed in the inside tube 20 in the formof a droplet, which would have less surface area than an evenlydispersed material inside the tube 20.

Preferably the selected material 32 that is to be dispensed from thedispensing tube 20 comprises lyophilized cells of one or more probioticmicroorganisms, such as various Lactobacillus or Bifidobacteria strains.Depending on the type of additive being added to tube 20, the suspensioncontaining the additive may need to specially treated to optimize shelfstability and appropriate retention in, and release from, tube 20. Forbacteria, the suspension containing the bacteria should not contain asignificant amount of water, and should be fairly resistant tooxidation. The suspension should dissolve or release or carry theadditive, such as bacteria, into the fluid that is being consumed, attypical use temperatures (e.g., 0° C.-40° C.). Thus, for a number ofadditives such as bacterial additives, the dried additive is preferablygranulized into a very fine powder to insure solubility and evendistribution in the solution.

The bacterial suspension or other additive to be contained in the deviceis preferably prepared in a sufficiently concentrated formulation sothat surface tension/adhesion withholds the suspension in the tube. Theconcentration of the suspension is optimized to give a good ratiobetween volume and number of bacteria per ml. Preferably theconcentration of bacteria is not lower then 1% in the suspension. Thecells are preferably mixed directly into the suspending liquid under anitrogen protective flow to reduce vapor and oxygen presence. Althoughcells of bacteria would not be visible to the naked eye, the selectedmaterial 32 is depicted in the figures as small dots, or as smallcircles, to show their position (e.g., in FIGS. 1-4 and FIG. 5,respectively).

Other selected materials that could be added to liquids using the deviceof the invention include vitamins, colorants, minerals, trace elements,homeopathic medicines, drugs, enzymes and the like.

The selected material 32, such as bacterial cells, is preferably addedto the tube 20 by providing a second tube 34 having a smaller outerdiameter than the inner diameter of the liquid impermeable tube andpreferably having a closed end 36 as shown in FIGS. 6A-6C. The closedend 36 is coated externally with the selected material 32 as shown inFIG. 6A, which adhere by surface tension and/or by use of an adhesivematerial as is known in the art. Then the coated closed end 36 isinserted into the bore 22 at the lower end 28 of the liquid impermeabletube 20 which has been treated in part or entirely with the coatingmaterial 30 (FIG. 6B). The closed end 36 is moved, such as beingrotated, against the coating material, thereby dislodging selectedmaterial that then adheres to the coating on the inner wall (FIG. 6C).

The tube 20 is preferably packaged in a flexible, essentially watervapor tight envelope 40 enclosing the tube 20 as shown in FIG. 7. Theouter envelope must be substantially impermeable to water vapor andshould have sufficient flexibility and toughness to preventunintentional puncture, and is preferably made of flexible polymericmaterial or an aluminum foil, coated on a polymeric film. In all casesthe envelope construction is made in such a way that when sealed, waterand moisture are prevented from entering the tube device. The materialshould also be easy to tear open at the point of use. The envelope 40 ispreferably made of a polyolefinic material coated with aluminum or of asynthetic polymer as is known in the art with a low water permeationrate. A preferred material for the outer envelope is a polyethylene orpolypropylene, including both homopolymers and copolymers of thesepolymer families, with an aluminum layer as an outer layer. If atransparent envelope 40 is desired, the polyethylene/polypropylenestructure may have outer layer comprising a polymer of ethyl vinylalcohol or poly-vinylidene chloride. Alternatively, polyethylene and/orpolypropylene may be used without an aluminum layer if there is not aneed for protection from oxygen. Those of ordinary skill in the art maysubstitute other suitable packaging material.

To use the impermeable tube 20, it is removed from envelope 40, andinserted into a chosen liquid container by either lowering it through anopening in the container as is done with standard straws, or bypuncturing a puncturable port on the container as is done with juicecartons. The port of the container, such as a juice box, to which thebacteria are to be added (not shown) may be protected by for instance apuncturable aluminum foil as is known in the art that will make itpossible to add bacteria to an aseptic filled or a thermally sterilizedsolution. At the time of the straw's penetration of the container, forexample, of an enteral product, a dairy product, a soft drink or someother type of solution or mixture, the bacteria are integrated into thesolution, giving a desirable dose of bacteria in the product. Once thelower end 28 of the tube is immersed in the liquid and the selectedmaterial 32 is removed from the inner tube wall 24 and mixed with theliquid by drawing the liquid through the bore from the lower end to theupper end and into the mouth.

The envelope 40 containing the tube 20 can be sold separately from thebeverage or other fluid containers, or can be attached to the container,for example, by adhesives as is known in the art for drinking containerstraws. Thus, tube 20 containing the selected material and in envelope40 could easily be attached onto every type of package containingsolutions where addition of the selected material would be suitable.

While the invention has been described with reference to specificembodiments, it will be appreciated that numerous variations,modifications, and embodiments are possible, and accordingly, all suchvariations, modifications, and embodiments are to be regarded as beingwithin the spirit and scope of the invention.

What is claimed is:
 1. A device for dispensing living cells of aprobiotic microorganism into a liquid. comprising: (a) a liquidimpermeable dispensing tube having an open bore being surrounded by aninner tube wall and extending from an open upper end of the tube to anopen lower end of the tube; (b) a coating material on a portion of theinner tube wall, said coating material selected from the groupconsisting of oils and waxes and holding a suspension of the livingcells of the probiotic microorganism for long-term storage within theopen bore adherent to the inner tube wall; and (c) a flexible,essentially water vapor tight envelope enclosing the tube for long-termstorage and to protect the living cells of the probiotic microorganismfrom moisture; wherein the living cells of the probiotic microorganismmay be removed from the inner tube wall and mixed with the liquid byplacing the open lower end of the tube in the liquid and drawing theliquid through the bore.
 2. The device of claim 1, wherein the probioticmicroorganism comprises Lactobacillus.
 3. The device of claim 1, whereinthe cells of a probiotic microorganism comprise a suspension oflyophilized live bacteria.
 4. The device of claim 3, in which theconcentration of live bacteria at the point of use is at least 1% of thesuspension when the device is manufactured.
 5. The device of claim 1,wherein the viscosity of the suspension is modified to provide maximumadherence of the suspension to the device.
 6. The device of claim 1,wherein the tube comprises a bellows portion.
 7. The device of claim 1,wherein the tube telescopes into an outer tube.
 8. The device of claim1, wherein the tube is made from a synthetic polymer material.
 9. Thedevice of claim 1, wherein the tube is made from paper with an internalcoating of a wax material.
 10. The device of claim 1, wherein the tubehas a diameter ranging from 0.2-20 mm and a length of 50-500 mm.
 11. Thedevice of claim 1, wherein the tube is a commercial drinking straw. 12.The device of claim 1, wherein the open bore of the tube has beensurface modified to give a higher surface tension.
 13. The device ofclaim 1, wherein the envelope is made of a polyolefinic material coatedwith aluminum.
 14. The device of claim 1, wherein the envelope is madeof a synthetic polymer with a low water permeation rate.
 15. The deviceof claim 1, wherein the suspension of cells is distributed along thefull length of the inner tube wall.
 16. The device of claim 1, whereinthe suspension of cells is primarily placed at the lower end of thetube.
 17. The device of claim 1, wherein the coating material comprisesa dietary oil.
 18. The device of claim 1, wherein the envelope comprisesan aluminum layer.
 19. A method of making a device for dispensing livingcells of a probiotic microorganism into a liquid, comprising: (a)providing a liquid impermeable dispensing tube having an open bore beingsurrounded by an inner tube wall and extending from an open upper end ofthe tube to an open lower end of the tube; (b) coating a portion of theinner tube wall within the open bore with a coating material selectedfrom the group consisting of oils and waxes and holding a suspension ofthe living cells of the probiotic microorganism for long-term storage sothat the coating material containing the living cells adheres to theinner tube wall; and (c) providing a flexible, essentially water vaportight envelope enclosing the tube for long-term storage and to protectthe living cells of the probiotic microorganism from moisture; whereinthe living cells of the probiotic microorganism may be removed from theinner tube wall and mixed with the liquid by placing the open lower endof the tube in the liquid and drawing the liquid through the bore. 20.The method of claim 19, wherein the inner tube wall is coated with thecells of the probiotic microorganism by insertion of a second tube thathas a coating of the cells of the probiotic microorganism into the lowerend of the dispensing tube.
 21. The method of claim 19, wherein theprobiotic microorganism comprises Lactobacillus.
 22. The method of claim19, wherein the cells of the probiotic microorganism comprise asuspension of lyophilized live bacteria.
 23. The method of claim 22, inwhich the concentration of live bacteria at the point of use is at least1% of the suspension when the device is manufactured.
 24. The method ofclaim 19, wherein providing the liquid impermeable dispensing tubecomprises providing a tube comprising a bellows portion.
 25. The methodof claim 19, wherein providing the liquid impermeable dispensing tubecomprises providing a tube that telescopes into an outer tube.
 26. Themethod of claim 19, wherein providing the liquid impermeable dispensingtube comprises providing a tube made from a synthetic polymer material.27. The method of claim 19, wherein providing the liquid impermeabledispensing tube comprises providing a tube made from paper with aninternal coating of a wax material.
 28. The method of claim 19, whereinproviding a liquid impermeable dispensing tube comprises providing atube having a diameter ranging from 0.2-20 mm and a length of 50-500 mm.29. The method of claim 19, wherein providing a liquid impermeabledispensing tube comprises providing a commercial drinking straw.
 30. Themethod of claim 19, further comprising surface-modification of the openbore of the tube to give a higher surface tension.
 31. The method ofclaim 19, wherein providing the flexible, essentially water vapor tightenvelope enclosing the tube comprises providing a polyolefinic materialcoated with aluminum.
 32. The method of claim 19, wherein providing theflexible, essentially water vapor tight envelope enclosing the tubecomprises providing an envelope made of a synthetic polymer with a lowwater permeation rate.
 33. The method of claim 19, wherein coating aportion of the inner tube wall comprises distributing the cells alongthe full length of the inner tube wall.
 34. The method of claim 19,wherein coating a portion of the inner tube wall comprises distributingthe suspension of cells at the lower end of the tube.
 35. The method ofclaim 19, further comprising modifying the viscosity of the suspensionto provide maximum adherence of the suspension to the device.
 36. Themethod of claim 19, wherein the coating material comprises a dietaryoil.
 37. The method of claim 19, wherein the envelope comprises analuminum layer.